Regulatory Affairs Certification (RAC) Practice Exam

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Which biological product is NOT regulated by CBER?

Immunizing toxoids
Monoclonal antibodies for in vitro use
Monoclonal antibodies for in vivo use
Infusion of animal sourced cells into a human

The correct answer is: Monoclonal antibodies for in vitro use

Monoclonal antibodies for in vitro use are not regulated by the Center for Biologics Evaluation and Research (CBER). Instead, these products fall under the jurisdiction of the Center for Devices and Radiological Health (CDRH) because they are considered to be laboratory tests, specifically diagnostic devices, rather than biological products intended for therapeutic use in humans. In contrast, immunizing toxoids, monoclonal antibodies for in vivo use, and the infusion of animal-sourced cells into humans are all regulated by CBER as they are classified as biological products due to their intended therapeutic applications. Understanding the distinctions between these regulatory pathways is crucial for navigating the complex landscape of regulatory affairs for biological products.